Probiotic combination for irritable bowel syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled trial testing a combination of two Limosilactobacillus reuteri strains (BG-R46™ and ATCC PTA 6475) in adults with IBS. 252 participants will be randomized 1:1 to take the probiotic or a matching placebo daily for 12 weeks, with a follow-up visit three months after treatment ends. Outcome measures include IBS symptom severity (IBS-SSS), oro-anal transit time, and a range of biological markers from blood, stool, saliva, and urine to explore mechanisms and predictors of response. Participants attend four in-person study visits for screening, randomization, end of intervention, and post-intervention follow-up while completing questionnaires throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with IBS according to ROME V criteria
* IBS-SSS greater than or equal to 75
* Adult over 18 years old
* BMI 18.5-35 kg/m2
* Able to understand the participant information sheet and willing to comply with the study protocol
* Able to give informed consent
* Able to complete the Swedish questionnaires

Exclusion Criteria:

* History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section).
* The use of opioids 1 month prior to screening and throughout the study
* The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components)
* Consumption of antibiotics 3 months prior to screening and throughout the study
* The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms.
* Participation in any medical research during the last month
* Clinically relevant lab abnormalities at the time of screening (fecal calprotectin greater than or equal to 150 ug/g as absolute cutoff. If calprotectin is between 50 - 150ug/g the decision is made on clinical judgement)
* Pregnancy, plan to become pregnant during the study, breastfeeding
* alcohol consumption \>14 units per week
* Use of recreational active drugs during 1 month before screening or during the study
* Use of medication that primarily affects bowel function, transit time, stool consistency 2 weeks before the intervention or during the 12 week intervention period

Where it's running

• Mag-tarmlab, Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting

Study contacts

• Principal investigator: Magnus Simren, MD PHD — Göteborg University
• Study coordinator: Magnus Simren, MD, PhD
• Email: magnus.simren@medicine.gu.se
• Phone: 0046313428107

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vitamin D Supplementation in Children with Irritable Bowel Syndrome

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• How certain FODMAPs affect IBS pain in adults

  This study tests whether adding back specific FODMAP types after a low-FODMAP diet can reveal which ones drive abdominal pain in adults with IBS.

  Recruiting Queen's University · Kingston, Ontario · NCT07688044

• Gut–brain gut study in IBS with anxiety and depression

  This study will compare people with IBS and mood symptoms to healthy volunteers to see if gut bacteria relate to brain function using questionnaires, stool and blood samples, and a brain MRI.

  Recruiting Tang-Du Hospital · Xi'an, Shaanxi · NCT07646834

• Pregabalin for irritable bowel syndrome in adults

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  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07635394

• Lyophilized donor gut bacteria capsules for treating irritable bowel syndrome

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  Recruiting Phase 1/2 University of Rijeka · Rijeka · NCT07481422

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.